FDA To Review Safety Of Abortion Pill After Junk Science Report Paved The Way

Yahoo

2 days ago

Republican Sen. Josh Hawley's quest to legitimize a junk science report undermining the safety of a widely used abortion pill was fully realized this week.
Food and Drug Administration Commissioner Martin Makary confirmed in a Monday letter to the Missouri senator that the agency will conduct a safety review of the abortion pill mifepristone. Makary's letter is in response to an April request from Hawley for the department to review mifepristone following a new report published by the Ethics and Public Policy Center, an anti-abortion conservative think tank and advisory board member of Project 2025.
'As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,' Makary wrote in his letter. 'As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data.'
The FDA and the Department of Health and Human Services did not immediately respond to HuffPost's request for comment.
Although Makary does not mention the EPPC report, Hawley's entire argument for reviewing mifepristone relies on the junk science paper. The EPPC report claims it's the 'largest-known study of the abortion pill' and that nearly 11% of women 'experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.' But data scientists voiced serious concerns about the validity of the report, pointing out that it's not peer-reviewed and the report's recommendations do not line up with the data they analyzed.
'It is highly concerning that the FDA is committed to a new review of mifepristone, given the massive amount of evidence on its safety and efficacy,' said Dr. Angel Foster, co-founder of the Massachusetts Medication Abortion Access Project, a shield law practice that provides telehealth abortion care to people in all 50 states.
'This is purely politically motivated and not rooted in science,' Foster said. 'Rolling back access to mifepristone would be a disaster, especially for the patients that The MAP serves every day – patients living in states where abortion is banned, who can't afford to pay for a procedure, and for whom neither traveling to another state nor remaining pregnant are options.'
Republicans have been laying the groundwork to undermine the safety of mifepristone for months. It makes sense that anti-abortion groups have set their sights on the pill: telehealth abortion care now accounts for 20% of all abortion care since the Supreme Court repealed Roe v. Wade.
Democrats have repeatedlygrilled Makary and HHS Secretary Robert F. Kennedy Jr. about their plans for mifepristone. The FDA commissioner's promise to review the abortion pill stands in stark contrast to his past statements that he has 'no plans' to restrict mifepristone. But Makary has repeatedly left the door open, hinting that if there was reason to believe mifepristone was unsafe his agency would review it.
Makary has not once stated mifepristone's proven safety record since the FDA approved it in 2000. The medication has been used safely by over 6 million people in the U.S., according to the agency. Major medical groups have repeatedly said mifepristone is safe, pointing to more than 100 studies that have corroborated its safety and effectiveness.
During a recent Senate appropriations hearing, Sen. Patty Murray (D-Wash.) asked Makary about the EPPC report and whether he would use it in his approach to mifepristone. Makary said he would want to see the underlying data of the study, but took issue with Murray's characterization of the EPPC paper as a 'sham study.'
'I have not seen that study, senator, and you have not seen that study,' Makary responded. 'So how can you call it a sham, bogus study? Neither of us have seen the study, the underlying data, or the methodology.'
The FDA did not respond to HuffPost when asked if Makary's decision to review mifepristone stemmed from the EPPC report or if he's seen its underlying data.
'Even apart from all the red flags with the data and supposed analysis, the fact where they land in the recommendations — that has nothing to do with the research itself — indicates this was driven more by ideology than by scientific rigor,' Rachel Jones, a principal research scientist at the Guttmacher Institute, said of the EPPC report in April.
Jones told HuffPost that she would not call the paper a 'study' since it's impossible for other researchers to fully assess the methodology and integrity of its results without access to the underlying data.
'We've known this moment was coming, and we've been sounding the alarm on Martin Makary since his nomination,' Reproductive Freedom for All President and CEO Mini Timmaraju said in a Tuesday statement.
'After months of signals and dog whistles, it's now in black and white on official FDA letterhead,' she continued. 'This review is not grounded in new data or real safety concerns – it's driven by Project 2025-aligned groups and right-wing politicians who want to ban abortion nationwide. We are now one step closer to the Trump administration's ultimate goal of a national abortion ban.'
GOP Lays Groundwork To Restrict Abortion Pill With New Junk Science Report
Trump DOJ Just Sided With Biden On Abortion Pill Case – But It's Not What You Think
Josh Hawley Introduces Law To Ban Mailing Of Abortion Pills, Citing Junk Science Report